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Botanicals

Introduction

Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements. Examples include ginkgo, garlic, St. John’s Wort and ginseng. Such products are typically labelled as natural foods and a variety of claims are made regarding their possible health benefits. They can be bought over the counter in pharmacies, supermarkets, specialist shops and via the internet. While most of these products have a long history of use in Europe, some concerns exist about their safety and quality. These include the risk of chemical or microbiological contamination and the need to ensure that concentrations of bioactive agents are within safe limits.

EFSA’s role

EFSA’s work in this field aims to provide any organisation assessing the safety of botanical ingredients with a science-based approach. It provides the criteria that should be taken into account when undertaking work to establish the safe use of botanicals or derived preparations.

This work was initiated in 2004 when the members of EFSA’s Advisory Forum underlined the need for science-based guidance for assessing the safety of botanicals. In 2009 EFSA published a toolkit to help assess the safety of botanicals and derived preparations which are intended for use in food supplements. The toolkit is intended for both risk assessors who want to consider the safety of a given botanical ingredient, and food manufacturers who are responsible for ensuring that the products they put on the market are safe.

The toolkit is composed of:

A guidance document identifying the data needed to assess the safety of botanicals and describing a science-based approach for the safety assessment.

A report with a number of examples illustrating how to apply the proposed scientific approach.

A Compendium of Botanicals that have been reported to contain substances that may be of health concern when used in food or food supplements. This compendium has been subject to regular updates.

EU framework

The EU does not have a centralised authorisation procedure for the use of botanicals and derived preparations in food. Nonetheless, the use of botanicals and derived preparations in food has to comply with the general requirements set out in Regulation (EC) No 178/2002, which lays down the general principles and requirements of food law in the EU. This assigns primary legal responsibility for the safety of the products placed on the market to business operators. Some botanicals are considered as traditional herbal medicinal plants and are used both in medicinal products and in food supplements. The European Medicines Agency (EMA) is responsible for assessing both the safety and efficacy of herbal preparations when used as medicines. It is not the role of EFSA or EMA to determine the classification of a botanical as a medicine or a food supplement.

Milestones

May-December 2016

EFSA’s Scientific Committee releases the third version of its Compendium; the database is expanded with non-European botanical species, and made more user-friendly with a web-based search interface.

March 2014

Scientific Committee publishes an opinion on the suitability of the Qualified Presumption of Safety approach for the assessment of botanicals and botanical preparations.

Scientific Committee publishes its guidance document for the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, a report testing the proposed approach for safety assessment with real case studies, and the Compendium of Botanicals reported to contain substances that may be of health concern.

April 2008

An EFSA Scientific Cooperation Working Group on botanicals and botanical preparations, composed of EFSA experts and experts from Member States, is created to test the proposed approach for the safety assessment with a number of botanicals, and to expand the Compendium on Botanicals.

August 2005

EFSA mandates its Scientific Committee to develop a science-based toolkit for the safety assessment of botanicals and botanical preparations.

June 2004

EFSA’s Scientific Committee publishes a discussion paper on botanicals and botanical preparations widely used in food supplements and related products. It expresses concerns about quality and safety issues, and highlights the need for a better characterisation of the range of products on the market and for harmonising risk assessment and consumer information approaches. EFSA’s Advisory Forum confirms the importance of the issues addressed by the paper for their countries.